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目的运用meta分析方法比较宫铜300宫内节育器(intrauterine device,IUD)与其它含铜IUD的妊娠率,对宫铜300有效性进行综合评估。方法通过计算机检索Pub Med、EMBASE、CENTRAL等9种数据库和WHO/FDA/IUD生产企业/临床试验注册相关网站,使用Open Meta-analyst和Rev Man 5.3.3进行数据分析与合并。结果初检文献6 062篇,根据纳入及排除标准,最终纳入20篇文献,均为随机对照试验(randomized controlled trial,RCT)或准RCT。分析结果显示:(1)宫铜300放置后第1月、6月及1年、2年、3年、5年、10年合并累计妊娠率分别为0.1%、0.2%、1.0%、2.6%、3.6%、3.5%、3.4%。(2)宫铜300放置1年和2年时累计妊娠率显著高于MCu功能型IUD(P<0.05),2年累计妊娠率显著高于元宫220(P<0.05)。结论宫铜300放置3年后累计妊娠率稳定在约3.5%;2年妊娠率高于MCu功能型和元宫220,未见与其他类型IUD妊娠率有差异。
Objective To compare the pregnancy rates of intrauterine device (IUD) and other copper-containing IUDs by meta-analysis and evaluate the effectiveness of Gong-Cu-300. Methods We searched 9 databases such as Pub Med, EMBASE and CENTRAL and related websites of WHO / FDA / IUD manufacturer / clinical trial registration by computer and used Open Meta-analyst and Rev Man 5.3.3 for data analysis and combination. Results A total of 6 062 subjects were included in the preliminary examination. According to inclusion and exclusion criteria, 20 articles were finally included, all of which were randomized controlled trial (RCT) or quasi-RCT. The results showed that: (1) The combined pregnancy rates at 1 month, 6 months and 1 year, 2 years, 3 years, 5 years and 10 years after application of Gong Cu 300 were 0.1%, 0.2%, 1.0% and 2.6% , 3.6%, 3.5%, 3.4%. (2) The cumulative pregnancy rate of Gong Cu 300 at 1 year and 2 years was significantly higher than that of MCu functional IUD (P <0.05). The 2-year cumulative pregnancy rate was significantly higher than that at Yuan Gong 220 (P <0.05). Conclusions The cumulative pregnancy rate of Gong-Cu-300 after three years of placement is stable at about 3.5%. The 2-year pregnancy rate is higher than that of MCu-type and Yuan-Gong 220, and there is no difference with other types of IUD pregnancy rates.